Manager Manufacturing Engineering and Maintenance

Sr Manager Manufacturing Engineering and Maintenance

Pharmaceutical Company Oral Solid Dosage experience

The Director is responsible for providing direction and leadership to the engineering supervisors which execute all Engineering related activities carried out on-site (automation, capital projects, utilities, equipment, etc.). Directly responsible for maintenance of utilities in the pharmaceutical manufacturing site. Responsible for the management of internal company assets, departmental personnel, external professional Engineering and other firms as part of the execution of equipment, facility or utility modification / upgrade, or expansion projects.

Support production volume.

Maintenance - Execute with the help of supervisors and mechanics, the planned and unplanned maintenance activities for all utilities equipment like HVACs, boilers, compressed air, chiller etc.

PM module – Monitor and work order status, follow up to close open work orders in timely manner.

Ensures timely PM and break down work order execution. Ensures work orders are closed and returned back to the maintenance planning group. Ensures routine PM is completed as specified.

Review and provide recommendations to improve PM work to reduce down time.

Maintain manufacturing and pkg. machines to perform at optimum performance level to meet production targets

Utilities – Maintain HVAC Systems, USP Water, Boilers, Compressed Air, Hot Water and Electricity available in quality and quantity to meet production targets. Includes all safety and security systems.

Facility – Maintain facilities all the time to acceptable level of FDA, OSHA and environmental agency compliance.

Maintenance Budget – Support preparation for annual maintenance budget. Forecast major activities and approximate expenses.

Review and monitoring the monthly expenses, try to contain expenses within budgets, without affecting quality and output.

Coordinates major shut downs with manufacturing and project. Coordinates utility, fire and security systems shut downs with Project management.

Evaluate and plan maintenance work force with the help of supervisors to meet production requirements

Capital Projects – Support planned activities from annual budgets $10,000 up to $ 1Mn. Prepare capital project proposals in line with the requirements, implementation and timely completion. Follow company policy for execution. Provide engineering support for evaluation of new machines.

Compliance –

Maintain Engineering Documentation up to date to the requirements of FDA, EU, OSHA, Environmental, Local Township, Insurance Carrier, and NFPA.

Review, renew and update SOP's.

Provide support to create, close CCR, Investigations in Trackwise appropriately and in timely manner.

Prepares site for any audits. Implements audit report recommendations

New Product Launches – Coordinate and provide appropriate support to Product Development and Production to launch products in time.

Organizes training and development programs for supervisors, team leads and mechanical staff.

Works with Maintenance planning on best practices for work order and spare parts systems.

Coordinates emergency services at site.

This is supervisory position with direct reports; therefore, this position will establish goals and objectives, prepare performance appraisals, monitor/review work product and coach/mentor direct reports.

Education and Job QualificationBachelor's Degree in Mech./Electrical Engineering preferred

Demonstrated excellent communication: verbal, written and presentation skills.

A self-starter with a hands-on approach and a can-do attitude.

A team building champion driving innovative cross functional synergies.

Excellent project management and problem solving skill

Minimum of Ten (8-10) years in Pharmaceutical, Oral Solid Dosage manufacturing company

Reports to VP Operations.